Biofluid Focus Announces -80°C PharmaTainer Test Results

December 2008:262017

Manufacturer, Cellon SA, developed a positive pressure gas leak test to demonstrate the effectiveness of the PharmaTainer double-seal closure system

An important test took place to show how effective the PharmaTainer double-seal closure system is. Biofluid Focus who specializes in supplying single-use products for pharmaceutical and biotech industries has revealed the test results which was conducted by the manufacturer, Cellon SA.

Many biopharmaceuticals and biotech materials are frozen at -80°C to prolong their shelf life prior to packaging in their final, drug-delivery format. Therefore it is important for the manufacturer to know the performance characteristics of the chosen freezing container. It is not enough to know that the container materials are durable at such temperatures; performance should be tested. Therefore, PharmaTainer bioprocess containers have been tested for seal integrity and impact resistance (drop test).

Seal Integrity Testing

In order to demonstrate the effectiveness of the PharmaTainer double-seal closure system, the manufacturer, Cellon SA, developed a positive pressure gas leak test. Bottles were filled with water to the nominal volume to reduce the volume of gas within the bottle, enabling small changes in air volume to become detectable over a short period of time.

Representative container were chosen for each closure sizes, 2 liter containers for 48/49mm closures and 5 liter for 70mm closures. Test articles were modified by mounting stainless steel airtight PU hose connection to provide an airtight seal onto the bottles. Containers were filled with water to 2L a 5L respectively, reducing the contained gas volume to the head-room of each container. The test containers were capped and torque applied 8Nh or 70 inlb, the manufacturer’s recommendation for freezing applications.

Subsequently, gas was pushed into the test bottles to an over-pressure of approximately 280mbar. After pressure stabilization, test articles were immersed into acryogenic container filled with dry ice and ethanol, until the water in the bottle had frozen to -80°C. After 3 days, the bottles were removed from the cryogenic container and allowed to thaw to ambient room temperature.

Pressure and temperature in the test bottle were continuously recorded during the entire freeze-thaw process. Positive gas pressure was maintained in the bottles after single and double freeze thaw cycles indicating that the integrity of the seal between the PharmaTainer bottle and closure was maintained.

Drop Test

Drop testing of 1O and 20 liter PC PharmaTainer™ car boys demonstrated container integrity and impact resistance when dropped frozen at -80°C. Tests were performed in accordance to ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems and D880Standard Test Method for Impact Testing for Shipping Containers and Systems.

Test containers were filled to their rated capacity (10L or 20L) with water and sealed to the recommended torque(8Nm/70in lb). The carboys were put in a freezer at -80°C and stored for 2 days until the carboys stabilized at -80°C.

Subsequently, test samples were dropped from a height of 533mm (21in.) onto a flat concrete surface three times; once from the base, once from a side and once inverted from the closure.

A sub-set of the test articles were re-tested from a height of 1100mm (43in.)

Thereafter the test carboys were allowed to thaw and observed for leaks. All tested container passed at both heights. There were some minor scratches but no loss of integrity.

Conclusion

These tests demonstrated that PharmaTainer PC carboys are well suited to secure containment at -80°C. Although smaller containers were not drop tested, it seems reasonable to infer their impact resistance would be adequate to pass the tests.

Eliminating or reducing the need for in-house container processing. Our featured line of PharmaTainer rigid bioprocess containers is manufactured by Cellon SA in Luxembourg. Biofluid Focus is their master distributor for North America.